More Proof Lung Cancer is Not One Disease: New Investigational Treatment, Nintedanib* Plus Chemotherapy, Extends Life of Lung Cancer Patients With Adenocarcinoma
New trial results presented at American Society of Clinical Oncology
(ASCO) 2013 represent first advance in almost a decade in overall
survival for patients where initial chemotherapy has failed
BURLINGTON, ON, June 3, 2013 /CNW/ – New research on Canada’s number one
cancer killer(1) is further proof that patients need personalized treatments targeted to
their specific type of lung cancer for better outcomes. Boehringer
Ingelheim (Canada) Ltd. today announced highly anticipated results from
the Phase III LUME-Lung 1 study in patients with advanced non-small
cell lung cancer (NSCLC). The primary endpoint was progression-free
survival (PFS) and the results showed patients treated with nintedanib
plus chemotherapy (docetaxel) lived for a median of 3.4 months before
their tumour started to grow again, versus 2.7 months with docetaxel
alone (HR 0.79; p=0.0019).(2 )The study also examined the secondary endpoint of overall survival (OS),(2) and in the process uncovered a specific group of patients who respond
particularly well to the combination therapy.
The trial examined a sub-group of patients with adenocarcinoma histology
– the most common type of NSCLC.(3 )It showed that patients with adenocarcinoma whose disease progressed
during first-line therapy or shortly after lived for an additional 2.3
months in the nintedanib combination treatment arm versus with
docetaxel alone. Specifically, the median overall survival (the gold
standard measure of success in lung cancer treatment) was 12.6 months
in the nintedanib combination treatment arm versus 10.3 months with
docetaxel alone (HR 0.75; p=0.0073).(2 )
“These study results are significant because they show us that
nintedanib may become an interesting option for some subsets of
patients with lung cancer,” says Dr. Normand Blais, medical oncologist
at the Centre Hospitalier de l’UniversitÃ© de MontrÃ©al (CHUM) in
Montreal. ”This is big news for the lung cancer community because
patients progressing after a first-line treatment need more efficient
treatments to control their cancers. As an oncologist I want to
offer my patients the best treatment options available and it is
encouraging to see new options in development that may help us devise
more efficacious and individualized treatment approaches.”
“Personalized medicine has changed the face of lung cancer treatment and
we now know lung cancer is not just one disease, so we need to consider
this when conducting new research,” said Dr. Mathias Knecht M.D., Vice
President Medical and Regulatory Affairs, Boehringer Ingelheim (Canada)
Ltd. “For this reason Boehringer Ingelheim is investigating two drugs
for NSCLC – afatinib* and nintedanib* – both which address the unmet
needs of two distinct lung cancer patient populations. These most
recent nintedanib results represent some of the latest advancements
from Boehringer Ingelheim’s robust oncology pipeline.”
About the LUME-Lung 1 Trial
LUME-Lung 1 (Clinical Trial Identifier: NCT00805194)is a randomized,
open-label, double-blind Phase III study evaluating nintedanib plus
docetaxel in patients with locally advanced or metastatic (stage
IIIb/IV or recurring) non-small cell lung cancer (NSCLC) after prior
first-line therapy, compared to docetaxel plus placebo. The study
included 1,314 patients in Europe, Asia and South Africa,(4) randomized to receive nintedanib 200 mg BID plus docetaxel 75mg/m(2) once a day, for three weeks (n=655) or docetaxel plus placebo (n=659).(2)
The primary endpoint was PFS; results showed patients treated with
nintedanib plus docetaxel lived for a median of 3.4 months before their
tumour started to grow again, versus 2.7 months with docetaxel alone
(HR 0.79; p=0.0019).(2 )
The secondary endpoint of OS was evaluated in the full study population,
as well as in the sub-group of patients with adenocarcinoma histology -
the most common type of NSCLC.(3 )Overall survival was evaluated in the following sequence: patients with
adenocarcinoma histology whose disease progressed during first-line
therapy or shortly after (less than 9 months since the start of
first-line therapy); all patients with adenocarcinoma histology; and,
all study participants (full study population). In the group of
patients with adenocarcinoma histology whose disease progressed during
first-line therapy or shortly after, the median OS was 10.9 months in
the nintedanib combination treatment arm versus 7.9 months with
docetaxel alone (HR: 0.75; p=0.0073).(2) In all patients with adenocarcinoma histology, the median OS was 12.6
months in the nintedanib combination arm versus 10.3 months with
docetaxel alone (HR: 0.83; p=0.0359).(2) In the full study population, the median OS was 10.1 months in the
nintedanib combination arm versus 9.1 months with docetaxel alone (HR
0.94; p=0.272).(2 )
The most common adverse events (AEs) in LUME-Lung 1 were
gastrointestinal side effects and liver enzyme elevations which were
manageable by supportive treatment or dose reduction (adverse events
placebo vs. nintedanib: nausea 18 per cent vs. 24 per cent, vomiting 9
per cent vs. 17 per cent, diarrhoea 22 per cent vs. 42 per cent and
liver enzymes 8 per cent vs. 29 per cent).(2)
LUME-Lung 1 is part of the wider Boehringer Ingelheim LUME-Lung Phase
III program for nintedanib investigating the safety and efficacy of
nintedanib in NSCLC patients after first-line chemotherapy treatment.
About Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common form of lung cancer, accounting for about 85
per cent of all diagnoses.(5 )Adenocarcinoma is the most common type of NSCLC, accounting for 40 per
cent of all NSCLC diagnoses.(3)
About Lung Cancer in Canada
According to the Canadian Cancer Society, in 2012 an estimated 25,600
Canadians were diagnosed with lung cancer,(6) and 20,100 died from it.(7) In fact, more people were estimated to die from lung cancer in 2012
than from colorectal, breast and prostate cancer combined.(8) As the leading cause of cancer death in both men and women in Canada,(9) its estimated an average of 55 Canadians die from lung cancer every
Lung cancer is also grossly under researched and under-funded. It only
gets 7 per cent of cancer-specific research funding and 0.1 per cent of
cancer donations, despite the fact that it causes 27 per cent of
Notes to Editors:
Nintedanib (BIBF 1120) is an investigational orally-administered triple
angiokinase inhibitor that targets three of the receptor tyrosine
kinases shown to aid in the regulation of angiogenesis: fibroblast
growth factor (FGF) receptor, platelet-derived growth factor (PDGF)
receptor, and vascular endothelial growth factor (VEGF) receptor.
Nintedanib is being evaluated in various solid tumours – including
advanced non-small cell lung cancer (NSCLC), ovarian cancer, liver
cancer (hepatic cell carcinoma), kidney cancer (renal cell carcinoma)
and colorectal cancer. The advanced NSCLC and ovarian cancer clinical
trials are in Phase III development. Nintedanib is also being
investigated in Phase III trials for the treatment of Idiopathic
Pulmonary Fibrosis (IPF), a progressive and severely debilitating lung
disease. Nintedanib is not approved by Health Canada; its safety and
efficacy have not been established.
About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of
pulmonary and cardiovascular medicine, metabolic disease, neurology,
virology and immunology, Boehringer Ingelheim has embarked on a major
research program to discover and develop innovative cancer treatments.
Working in close collaboration with the international scientific
community and a number of the world’s leading cancer centers,
Boehringer Ingelheim’s commitment to oncology is underpinned by using
advances in science to develop a range of targeted therapies for
various solid tumours and hematological cancers. The current focus of
late-stage research includes compounds in three areas: signal
transduction inhibition, angiogenesis inhibition and cell-cycle kinase
inhibition. The company is also evaluating a robust and growing
pipeline of early-stage oncology compounds in areas including
growth/survival signaling, immunotherapy and epigenetics.
About Boehringer Ingelheim (Canada) Ltd.
The Boehringer Ingelheim group is one of the world’s 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 140 affiliates and more than 46,000 employees.
Since it was founded in 1885, the family-owned company has been
committed to researching, developing, manufacturing and marketing novel
medications of high therapeutic value for human and veterinary
As a central element of its culture, Boehringer Ingelheim pledges to act
socially responsible. Involvement in social projects, caring for
employees and their families, and providing equal opportunities for all
employees form the foundation of the global operations. Mutual
cooperation and respect, as well as environmental protection and
sustainability are intrinsic factors in all of Boehringer Ingelheim’s
In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion
euro. R&D expenditure in its Prescription Medicines business
corresponds to 22.5% of its net sales.
The Canadian headquarters of Boehringer Ingelheim was established in
1972 in Montreal, Quebec and is now located in Burlington, Ontario.
Boehringer Ingelheim employs more than 550 people across Canada. For
more information please visit www.boehringer-ingelheim.ca.
(1) Canadian Cancer Society’s Steering Committee on Cancer Statistics. Canadian Cancer Statistics 2012. Toronto, ON: Canadian Cancer Society; 2012, Page 9.
(2) Reck M. Nintedanib (BIBF 1120) + docetaxel in NSCLC patients progressing after
first-line chemotherapy: LUME Lung 1, a randomized, double blind phase
3 trial. Oral Presentation (Abstract #LBA8011) at American Society of
Clinical Oncology, Chicago, June 2, 2013.
(3) American Cancer Society. Lung Cancer (Non-Small Cell). Available at:
http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf. Last Accessed May 7, 2013.
(4) ClinicalTrials.gov. LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus
Docetaxel in 2nd Line Non Small Cell Lung Cancer. Available at: http://clinicaltrials.gov/ct2/show/study/NCT00805194?show_locs=Y#locn. Last accessed May 21, 2013.
(5) American Cancer Society. Cancer Facts and Figures: 2012. Available at: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-031941.pdf. Last accessed April 27, 2012.
(6) Canadian Cancer Society’s Steering Committee: Canadian Cancer Statistics 2012. Toronto, ON:
Canadian Cancer Society; 2012, Page 8.
(7) Canadian Cancer Society’s Steering Committee: Canadian Cancer Statistics 2012. Toronto, ON:
Canadian Cancer Society; 2012, Page 9.
(9) Canadian Cancer Society’s Steering Committee: Canadian Cancer Statistics 2012. Toronto, ON:
Canadian Cancer Society; 2012, Page 7.
(10) Canadian Cancer Society’s Steering Committee: Canadian Cancer Statistics 2012. Toronto, ON:
Canadian Cancer Society; 2012, Page 9.
(11) Charity Intelligence Canada: Cancer in Canada. April 2011. Page 39.
*Afatinib and Nintedanib are investigational compounds. Their safety and
efficacy have not yet been fully established and they are not currently
authorized for sale in Canada.
SOURCE Boehringer Ingelheim (Canada) Ltd.
Video with caption: “Video: Dr. Vera Hirsh, Associate Professor, McGill University, Department of Medical Oncology, Royal Victoria Hospital, Montreal, Canada talks about a new era of personalized medicine in lung cancer.”. Video available at: http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20130603_C4194_VIDEO_EN_27364.mp4&posterurl=http://photos.newswire.ca/images/20130603_C4194_PHOTO_EN_27364.jpg&clientName=Boehringer%20Ingelheim%20%28Canada%29%20Ltd%2E&caption=Video%3A%20Dr%2E%20Vera%20Hirsh%2C%20Associate%20Professor%2C%20McGill%20University%2C%20Department%20of%20Medical%20Oncology%2C%20Royal%20Victoria%20Hospital%2C%20Montreal%2C%20Canada%20talks%20about%20a%20new%20era%20of%20personalized%20medicine%20in%20lung%20cancer%2E&title=BOEHRINGER%20INGELHEIM%20%28CANADA%29%20LTD%2E%20%2D%20More%20Proof%20Lung%20Cancer%20is%20Not%20One%20Disease%3A%20New%20Investigational%20Treatment%2C%20Nintedanib%2A%20Plus%20Chemotherapy%2C%20Extends%20Life%20of%20Lung%20Cancer%20Patients%20With%20Adenocarcinoma&headline=More%20Proof%20Lung%20Cancer%20is%20Not%20One%20Disease%3A%20New%20Investigational%20Treatment%2C%20Nintedanib%2A%20Plus%20Chemotherapy%2C%20Extends%20Life%20of%20Lung%20Cancer%20Patients%20With%20Adenocarcinoma